Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care.

Caregivers of patients undergoing HSCT will receive the PATH-C intervention to learn to reflect on their positive emotions and consistently use and incorporate positive psychology exercises in their daily routine, as well as learn how to set goals and track their physical activity (i.e., with an activity tracker) daily while caring for a loved one undergoing HSCT.

Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.

Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to PATH-C versus usual care.

Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.

Participants in the usual care arm will receive their usual support from the HSCT team as caregivers of patients undergoing HSCT, including all routine supportive care resources (e.g., support from social work) offered by the HSCT team.

Patients in the usual care and PATH-C groups will be permitted to use all supportive care services per standard care. The investigators will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).

PATH-C, a phone-delivered positive psychology intervention for caregivers of patients undergoing HSCT, consists of the following nine sessions: 1) Enhancing gratitude and increasing awareness for physical activity; 2) Expressing gratitude and goal setting for physical activity; 3) Integrating gratitude and goals for physical activity; 4) Personal strengths and environmental scan to enhance physical activity; 5) Enhancing strengths via reflection on past successes; 6) Integrating strengths to enhance well-being and physical activity; 7) Engaging in enjoyable and meaningful activities; 8) Promoting optimism and integrating long-term activity habits; 9) Integrating meaning for sustainable physical activity goals. Each session takes about 30 minutes, and a trained interventionist will guide participants to complete the sessions.

PATH-C

Hermioni Amonoo, MD, MPP, MPH

Annabella Boardman, BA

Hermioni Amonoo, MD, MPP

The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).

Family and friend caregivers are vital care providers throughout the entire care continuum for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). These caregivers must manage multiple time-consuming responsibilities, including monitoring vital signs and side effects of treatment, administering medications, and coordinating transportation to and from medical appointments. The substantial caregiving burden among caregivers of patients undergoing HSCT is associated with increased symptoms of depression, anxiety, and fatigue. Symptoms such as fatigue and depression in HSCT caregivers may undermine attempts to maintain regular physical activity routines, which may impact essential health outcomes such as cardiovascular health.

With persistent shortages in the mental health workforce needed to address these psychological needs of HSCT caregivers adequately, remotely-delivered psychosocial interventions offer an innovative approach to overcome the unmet psychological needs of this population. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells for Caregivers (PATH-C), tailored to the unique psychological needs of HSCT caregivers. With this study, the investigators will establish the impact of PATH-C on participant-reported outcomes compared to usual care.

The study will use validated questionnaires to measure caregivers' quality of life, caregiver burden, psychological distress symptoms, positive psychological well-being (e.g., positive affect, gratitude), and self-management targets (e.g., coping, self-efficacy). The study will also use the validated ActiGraph GT3X+ accelerometer to measure minutes/day of moderate-to-vigorous physical activity, light activity, and sedentary leisure time.

This is a single-site randomized efficacy trial of the PATH-C intervention in 80 caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. Participants will be recruited from the Dana-Farber Cancer Institute and randomized in a 1:1 fashion, stratified by transplant type (autologous versus allogeneic), to assign each participant to either PATH-C versus usual care.

A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors

Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors

The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Compare optimism using the 10-item Life Orientation Test-Revised (LOT-R) between the two groups.

The LOT-R ranges from 0 to 24, with higher scores indicating greater optimism.

Compare positive affect using the 15-item Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Short Form between the two groups.

The PROMIS Positive Affect Short Form ranges from 15 to 75, with higher scores indicating greater positive affect.

Compare life satisfaction using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction Questionnaire between the two groups.

The PROMIS General Life Satisfaction Questionnaire ranges from 10 to 60, with higher scores indicating greater satisfaction with life.

Compare gratitude using the 6-item Gratitude Questionnaire between the two groups.

The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.

Compare flourishing using the 8-item Flourishing Scale between the two groups.

The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths.

Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups.

The CASE-t ranges from 0 to 170, with higher scores indicating greater self-efficacy.

Compare coping skills using the Measure of Current Status (MOCS-A) between the two groups.

The MOCS-A ranges from 0 to 52, with higher scores indicating having more coping skills.

Compare stress resilience using the 6-item Brief Resilience Scale (BRS) between the two groups.

The BRS ranges from 6 to 30, with higher scores indicating greater stress resilience.

Compare locus of control using the Multidimensional Health Locus of Control (MHLC) scale, Form A between the two groups.

The MHLC Form A ranges from 6 to 36 for each locus of control category (internal, powerful others, or chance), and higher scores suggest greater belief in each category as the source of health locus of control.

PATH-C Intervention Feasibility is defined as \>60% of eligible participants enrolling in the study and \>60% of enrolled participants who start the intervention completing at least 6/9 intervention sessions.

Acceptability will be measured using weekly ratings of the ease and utility of each exercise (0=very difficult/not helpful; 10=very easy/very helpful) and will use a threshold of a mean combined score of 7.0/10.0.

Compare physical activity levels using the ActiGraph GT3X+ accelerometer between the two groups.

Greater steps/day and lower sedentary leisure time indicate greater physical activity.

Compare caregiver quality of life using the 29-item CareGiver Oncology Quality of Life questionnaire (CarGOQOL) between the two groups.

Higher scores on the CarGOQOL (normalized score range, 1-100) indicate better quality of life.

Compare anxiety symptoms using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale between the two groups.

The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms.

Compare depression symptoms using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale between the two groups.

The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms.

Compare caregiving burden using the 24-item Caregiver Reaction Assessment (CRA) between the two groups.

The CRA ranges from 24 to 120, with higher scores indicating greater caregiving burden.

Dana-Farber Cancer Institute

Robert Wood Johnson Foundation

American Society of Hematology

Brigham and Women's Hospital

Director, Well-Being and Cancer Research Program

Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.

After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).

Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.

Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.

Positive Psychology Intervention

Hermioni L Amonoo, MD, MPP

Caregivers (i.e., family and friends) of patients with cancer are essential in providing care during cancer treatment. For patients who are undergoing a stem cell transplant (SCT) as treatment for their cancer, caregivers are even more crucial before, during, and after their transplantation. Although SCT is potentially curative for some patients with blood cancers, the treatment is intensive and accompanied by a prolonged hospitalization as patients recover from the toxic side-effects of chemotherapy and medical complications from the transplantation. Unsurprisingly, during the entire transplantation process, caregiver burden is high as caregivers witness and support their loved ones through multiple treatment related complications, management of ongoing physical symptoms and complex medication schedules. Caregiver burden leads to poor health outcomes including poor caregiver quality of life, fatigue, depression, anxiety, impaired physical health, low levels of resilience and positive emotions. Reducing distress and enhancing positive emotions can both reduce caregiver burden and improve caregiver quality of life. However, the few interventions in the SCT caregiver population have mostly focused on mitigating distress, despite strong evidence that enhancing positive emotions in caregivers reduces caregiver burden and promotes physical and psychological health. To address this gap, we hope to develop and test an intervention that emphasizes positive emotions in caregivers of SCT recipients. A scalable and accessible positive emotion based intervention tailored to the unique needs of SCT recipient caregivers provides a new line of behavioral intervention resources that could confer benefit to both caregivers and patients and could be generalizable to other cancer caregivers.

The proposed project (PATH-C) entails two phases:

1. Phase one is an open-pilot trial in 5 caregivers of patients undergoing HSCT to refine the PATH intervention.
2. Phase two is one-arm trial evaluating the feasibility and acceptability of the PATH intervention in 20 caregivers of patients undergoing HSCT.

All participants will be approached in person at the routine HSCT patient consent clinic visit or with patient permission over the phone if caregiver is not physically present at the consent visit for eligibility determination. Interested participants will be screened based on the inclusion/exclusion criteria and verbal consent would be obtained (via phone).

Upon consent to participate in the study, participants in Phase-2 will be asked to complete baseline questionnaires either in-person, over the phone, or via a REDCap survey link to participants. After baseline assessments are completed, participants will be given an intervention manual with 9-weekly PP exercises and an explanation of the exercises and intervention.

Participants in Phase-1 will complete the intervention after consenting for the study. All participants in Phase-2 will be asked to complete the 9-weekly PP exercises starting after the baseline questionnaires (i.e., after the patient transplant consent visit) are completed in the pre-transplant phase and to speak with the study interventionist, a trained CRC, weekly. Immediately after the completion of each exercise, participants will rate the ease of exercise completion, overall utility of the exercise, and their current levels of positive affect. After the Week 9 intervention phone session, participants in Phase-2 will repeat self-assessment questionnaires completed at baseline either over the phone, in-person at a routine clinic visit, or via a REDCap survey link emailed to participants. Additionally, participants will be asked to complete a recorded exit interview over the phone. These individual, semi-structured exit interviews will elicit feedback about the intervention (e.g., relevance and applicability of the chosen PP exercises, intervention length, timing, and delivery), study procedures, and the questionnaires. Exit interviews will be recorded, transcribed, coded and thematically analyzed. At study completion, we will inquire about participants' potential interest in being contacted about our future studies.

Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of HSCT Patients

Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Refinement of a positive psychology intervention (PATH) in caregivers of HSCT recipients based on findings from an open-pilot study (N=5).

Feasibility and acceptability of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone HSCT using a single-arm trial (N=20).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors	NCT06153797	Hematologic Mal... Caregiver	PATH-C	18 Years -	Brigham and Women's Hospital
Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of HSCT Patients	NCT05216978	Caregiver Hematologic Mal...	Positive Psycho...	18 Years -	Brigham and Women's Hospital
A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors	NCT06153797	Hematologic Mal... Caregiver	PATH-C	18 Years -	Brigham and Women's Hospital

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